What are the responsibilities and job description for the Manufacturing Engineer position at Intellectt Inc?
Job Title: Manufacturing Engineer (Medical Device Industry)
Location: Minneapolis, Minnesota, USA
Duration: Long-term Contract (W2)
Key Responsibilities:
- Develop, implement, and maintain efficient manufacturing processes for medical devices, ensuring compliance with regulatory and quality standards.
- Identify and troubleshoot production issues, driving root cause analysis and implementing corrective actions.
- Collaborate with cross-functional teams to ensure smooth design transfer from R&D to manufacturing.
- Create and update process documentation, including standard operating procedures (SOPs), work instructions, and process flow diagrams.
- Perform process validation activities, including IQ, OQ, and PQ, to ensure robust manufacturing operations.
- Optimize production workflows, reduce waste, and implement lean manufacturing principles.
- Support continuous improvement initiatives to enhance productivity and reduce costs.
- Ensure compliance with FDA regulations, ISO 13485, and other relevant industry standards.
- Provide technical support and training to production staff.
Qualifications:
- Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
- Experience: 2 years of experience in manufacturing engineering, preferably in the medical device or related regulated industry.
- Strong knowledge of process validation and manufacturing process optimization.
- Familiarity with lean manufacturing, Six Sigma methodologies, and continuous improvement tools.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and manufacturing simulation tools.
- Experience with ERP/MRP systems for production planning and inventory control.
- Strong problem-solving and analytical skills with attention to detail.
- Excellent communication and teamwork abilities.
Preferred Skills:
- Hands-on experience with Class II or Class III medical devices.
- Certification in Six Sigma or Lean Manufacturing (e.g., Green Belt or Black Belt).
- Knowledge of automation and robotics in manufacturing.
- Experience with design transfer and scale-up of manufacturing processes.
- Familiarity with statistical analysis tools such as Minitab.
